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FDA (Device enforcement)Recalled 2017-05-11closedclass ii

GE Medical Systems, LLC: Discovery MR750 3.0T Product Usage: Intended use: The Discovery MR750 3.0Tsystem is a whole body magnetic resonance scanner designed to support high resolution, high signal-to

Is my product affected?

Discovery MR750 3.0T Product Usage: Intended use: The Discovery MR750 3.0Tsystem is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. It is indicated for use as a diagnostic imaging device to produce axial, sagittal, corona

  • UPC 00840682115971
  • UPC 00840682115872
  • UPC 00840682103817
  • UPC 00840682105699
  • UPC 840682105378

Check against the official notice below — it lists the full affected range.

What happened

GE Medical Systems is recalling 68 Discovery MR750 3.0T magnetic resonance imaging systems distributed nationwide across 22 states due to possible incorrect wiring of the Uninterruptable Power Supply that could create a potential shock hazard. The affected units are identified by multiple Medical Device Listing numbers and model numbers for the Eaton 9130 and related components.

The recall record does not specify a remedy or instructions for affected consumers.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

Possible incorrect wiring of the Uninterruptable Power Supply, which could contribute to a potential shock hazard.

Details from the source

Reason for recall: Possible incorrect wiring of the Uninterruptable Power Supply, which could contribute to a potential shock hazard. Distribution: US Nationwide in the states of : AK, CA, CO, CT, DE, FL, IA, IL, IN, KS, KY, LA, MD, MO, ND, NE, NJ, NY, OH, PA, TX, WA, and WI Quantity: 68 units in total Lot/code info: Medical Device Listing No. D117354, D295466, D182389, D102432, D206140, D230310, D269569, D102430, D140572, D188736, D102434, D234841, D196247, D134019, D236543, D006275, D159181, D288890, D229859; Model No. Eaton 9130, 5323286, 5396502-5, 5499460-3, 5499460-6, 5499460-9, 5741000-3, 00840682115971, 5396502-2, 5499460-2, 5741000-2, 00840682115872, 5373011-3, 5396469-3, 5481490-2, 5481500-7, 5499460-7, 5499460-10, 5741000, 00840682103817, 5323286-101, 2377062-61, 2395001, 2395001-2, 2395001-3, 2395001-4, 00840682105699, 840682105378

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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